BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12708406 · Received October 27, 2021

    Report

    Report Number
    9610877-2021-01243
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Report Date
    October 27, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333135899
    PMA / PMN Number
    K182004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE UNITED STATES WITHIN THE PAI REGION. THE CUSTOMER REPORTS THAT THERE WAS NO VIDEO IMAGE INVOLVING PENTAX MEDICAL ULTRASOUND VIDEO GASTROSCOPE MODEL EG3870UTK, SERIAL NUMBER (B)(4). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. NO ADDITIONAL INFORMATION PROVIDED WITH THIS COMPLAINT. THE USER FACILITY RESPONDED TO THE GOOD FAITH EFFORT REQUEST VIA EMAIL ON 01-OCT-2021. THE CUSTOMER STATED, "THIS ISSUE WAS FOUND DURING THE PRE PROCEDURE CHECK. THE PRE PROCEDURE CHECKLIST WAS DONE AND COMPLETED AND SCOPE WAS REMOVED FROM CIRCULATION." THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 01-OCT-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE CUSTOMER COMPLAINT OF IMAGE BLACKOUT AND DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: ELEVATOR WASHING SOCKET CYLINDER RUBBER CHIPPED, PVE ELECTRICAL PIN CORRODED, FAILED WET LEAK TEST, ULTRASOUND CONNECTOR CABLE DENT/ CRUSH, FAILED DRY LEAK TEST, BENDING RUBBER GLUE CRACKING AT INSERTION TUBE SIDE, BENDING RUBBER GLUE CRACKING AT DISTAL SIDE, DISTAL BODY ABRASION, ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - HI-POT, MILD MOISTURE IN CONTROL BODY, PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION, ULTRASOUND IMAGE HAS BROKEN CHANNEL, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, CCD CIRCUIT BOARD CORROSION, ELEVATOR WASHING SOCKET CYLINDER NUT MISSING, CONTROL BODY CORRODED, LEAK AT ELEVATOR WASHING SOCKET CYLINDER, MILD MOISTURE ON PVE ELECTRICAL CONNECTOR FRAME. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, PCB FOR CCD K3A PB-FREE/NTSC, ELECTRICAL CONNECTOR ASSY. THE ENDOSCOPE WAS REPAIRED AND APPROVED BY FINAL QC ON 12-OCT-2021 AND WAS DELIVERED TO THE CUSTOMER UNDER DELIVERY ORDER (B)(4). MODEL EG3870UTK, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605339 PENTAX VIDEO NASO PHARYNGO LARYNGOSCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG-3870UTK 04961333135899

    Patients

    Seq Age Sex Outcome Treatment
    1